CTRI/2020/09/027637已完成不适用
A Comparative Clinical Evaluation of the Safety and Effectiveness of a Monofocal Extended Depth of Focus Intraocular Lens for the Correction of Aphakia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Monocular Uncorrected Distance Visual Acuity at Form 4A.
研究概览
简要总结
Subjects scheduled to undergo cataract extraction and intraocular lens implantation will be screened for eligibility. Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline ocular condition. Subjects will be randomized in a 1:1 ratio and undergo small incision phacoemulsification cataract surgery and implantation with either the Mono-EDoF IOL Model ME4 or ME6 in the primary eye. Second eye surgery will occur at least two weeks following first eye surgery. Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults 40 years of age and older at the time of consent.
- •Cataract in both eyes.
- •Pre-operative corneal astigmatism < 1.0 D.
- •Calculated lens power from 18 D to 24 D.
- •Willing and able to return for all scheduled treatment and post-operative visits for a minimum of 6 months.
- •Planned removal of visually significant cataract (cortical, nuclear, posterior subcapsular, or a combination) by manual phacoemulsification cataract extraction in both eyes.
- •Willing to discontinue contact lens wear, if applicable, and demonstrate corneal stability prior to biometry and surgery.
- •Preoperative best corrected distance visual acuity (BCDVA) of 0.2 logMAR or worse, with or without a glare source.
- •Post-operative BCDVA projected to be 0.2 logMAR or better (as determined by the medical judgment of the Investigator or measured by potential acuity meter / retinal acuity meter (PAM / RAM) if necessary).
- •Pharmacologically dilated pupil size at least 6.0 mm.
- •Must be able to understand and provide informed consent themselves or through a representative with a witness present on the IRB or EC approved Informed Consent Form (ICF).
排除标准
- •Participation in any other drug or device clinical trial within 90 days prior to enrolling in this study and/or during study participation.
- •Pregnancy or lactation.
- •Subject who, in the clinical judgment of the Investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator (reason to be documented by the site on Case Report Forms.
- •Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria.
- •History of any intraocular or corneal surgery in either eye (including LASIK, PRK, LRI, etc.).
- •Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in either eye.
- •Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction (e.g., chronic uveitis, iritis, iridocyclitis, aniridia, rubeosis iridis, clinically significant corneal, Fuchs,anterior membrane distrophis,etc) in either eye.
- •Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation.
- •Any visually significant intraocular media opacity other than cataract in either eye.
- •History of any clinically significant retinal pathology or ocular diagnosis (e.g., diabetic retinopathy, ischemic disease, macular degeneration, retinal detachment, amblyopia, optic neuropathy, microphthalmos, aniridia, etc.) in either eye that could alter or limit final postoperative visual prognosis.
- •History of cystoid macular edema in either eye.
- •Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements.
- •Uncontrolled glaucoma in either eye.
- •Extremely shallow anterior chamber (< 2.0 mm).
- •Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes.
- •Irregular astigmatism, corneal degeneration or dystrophy.
- •Uncontrolled systemic disease (e.g., diabetes mellitus, active cancer treatment, mental illness, etc.) in the opinion of the investigator, would put the subjects health at risk and/or prevent the subject from completing all study visits.
- •Systemic medication that, in the opinion of the investigator, may confound the outcome or increase the intraoperative and post-operative risk to the subject (e.g., Tamsulosin Hydrochloride) or other medications including anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g., small pupil/floppy iris syndrome).
- •Subjects who may reasonably be expected to require any additional ophthalmic surgical intervention at any time during the study (other than YAG capsulotomy).
- •Need for concomitant procedures (e.g., glaucoma surgery, LRI, RK, LASIK, etc.).
- •Subjects with central endothelial cell density <2000 cells/mm2 .
结局指标
主要结局
Monocular Uncorrected Distance Visual Acuity at Form 4A.
时间窗: 80 - 100 days
次要结局
- - Monocular Distance Corrected Intermediate Visual Acuity at Form 4A(- Monocular Uncorrected Intermediate Visual Acuity at Form 4A)
研究者
研究点 (1)
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